GlaxoSmithKline

RSV is a contagious virus affecting lungs, nose, and throat, with severe impacts on infants and older adults. Preventive options include maternal RSV vaccine (Abrysvo) and monoclonal antibody injection (Beyfortus) for infants, and three vaccines for adults 60+ (Arexvy, Abrysvo, mResvia). Uptake remains low despite WHO recommendations.

A phase III trial (ENGOT-OV41/GEICO 69-O/ANITA) found no progression-free survival benefit with atezolizumab added to carboplatin doublet and maintenance niraparib in recurrent ovarian cancer patients with platinum-free interval > 6 months. Median progression-free survival was 11.2 months with atezolizumab vs 10.1 months with placebo, and maintenance progression-free survival was 6.7 months vs 5.3 months, respectively. The study concluded that combining atezolizumab with chemotherapy and niraparib did not significantly improve progression-free survival or objective response rate.

The European Medicines Agency is reviewing anti-hair loss drugs like Organon's Propecia due to risks of suicidal thoughts. The agency will decide whether to withdraw, suspend, or maintain marketing authorisations. Finasteride and dutasteride, known for psychiatric side effects, already carry warnings. The FDA rejected a 2022 request to remove Propecia but added a warning about suicidal thoughts.

The European Medicines Agency is reviewing finasteride and dutasteride, used for hair loss and enlarged prostate, due to concerns about suicidal thoughts. The French medicines agency requested the review, noting a 'reasonable possibility' of a link, despite no established connection. Organon, maker of Propecia and Proscar, supports the review process, while GSK's Avodart is also under scrutiny. The EMA will recommend whether these medicines' marketing authorizations should remain, change, or be withdrawn.

The European Medicines Agency is reviewing anti-hair loss drugs like Merck's Propecia for potential suicidal thoughts and behavior risks, considering withdrawal, suspension, or maintenance of their marketing authorisations.

Dr. Claire Wagner, head of corporate strategy and market access at the Bill & Melinda Gates Medical Research Institute, focuses on developing medications for diseases primarily impacting Low and Middle-Income Countries (LMICs), where commercial incentives are limited. The Gates MRI prioritizes global health equity, targeting diseases like tuberculosis, malaria, and diarrheal diseases. Wagner emphasizes the importance of policy alignment, innovative financing, and strong partnerships to ensure products reach those in need, drawing on her experience in Rwanda and collaborations with global health organizations. The institute is currently developing vaccines and therapeutics, including a TB vaccine candidate and a probiotic supplement for malnourished children.

Pharmaceutical companies are conducting clinical trials in Brazil and Turkey due to lower costs. Regulatory reforms by TITCK and ANVISA streamline approval processes, attracting major firms like AstraZeneca and Merck. Phase 3 trials for cancer drugs like Aflibercept and Savolitinib are underway. Collaboration with local institutions and CROs enhances trial quality and efficiency, positioning these countries as key clinical research hubs.

DelveInsight's 'Hepatocellular Carcinoma Pipeline Insight 2024' report details 90+ companies developing 95+ pipeline drugs for HCC, with therapies in various stages of clinical development, including collaborations and regulatory approvals.

Alembic Pharmaceuticals received USFDA final approval for Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg, therapeutically equivalent to GSK's Lamictal XR. Indicated for seizures in patients aged 13+, with a $163 million market size.

Alembic Pharmaceuticals receives USFDA approval for Lamotrigine Extended-Release Tablets, indicated for adjunctive therapy for seizures. The tablets are therapeutically equivalent to GlaxoSmithKline's Lamictal XR, with an estimated market size of $163 million.